Effect of Sarcosine on Symptomatology, Quality of Life, Oxidative Stress and Glutamatergic Parameters in Schizophrenia (PULSAR)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Medical Universtity of Lodz.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Dominik Strzelecki MD PhD, Medical Universtity of Lodz
ClinicalTrials.gov Identifier:
NCT01503359
First received: December 30, 2011
Last updated: February 1, 2012
Last verified: February 2012
  Purpose

The purpose of study is to determine whether dietary supplement sarcosine is effective in treatment of schizophrenia. The investigators will assess impact of sarcosine on quality of life and sexual functioning. In this project the investigators will also measure glycine, sarcosine, BDNF, MMP-9 levels and oxydative stress parameters in blood, brain glutamatergic metabolism parameters in magnetic resonance spectroscopy and oculomotoric changes in electrooculography.


Condition Intervention Phase
Schizophrenia
Dietary Supplement: Sarcosine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Sarcosine on Symptomatology, Quality of Life, Cognitive and Sexual Functioning, Blood Levels of Sarcosine, Glycine, BDNF and MMP-9, Oculomotor, Brain Metabolism and Oxidative Stress Parameters in Schizophrenia.

Resource links provided by NLM:


Further study details as provided by Medical Universtity of Lodz:

Primary Outcome Measures:
  • Assessment of sarcosine vs. placebo impact on schizophrenia symptoms using Positive and Negative Syndrome Scale (PANSS). [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Both arms, every visit


Secondary Outcome Measures:
  • Impact assessment of sarcosine versus placebo on the parameters of quality of life (QoL) and sexual functioning. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Both arms, every visit

  • Impact assessment of sarcosine versus placebo on depressive symptoms using Calgary Depression Scale for Schizophrenia. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Both arms, every visit

  • Impact assessment of sarcosine versus placebo on cognitive functions using Wisconsin Card Sort Test, Trail Making Test and Stroop Test. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Both arms, before and after taking sarcosine or placebo

  • Impact assessment of sarcosine versus placebo on oxidative stress parameters (T-BARS). [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Both arms, before and after taking sarcosine or placebo

  • Impact assessment of sarcosine versus placebo on brain metabolism parameters (magnetic resonance spectroscopy). [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Both arms, before and after taking sarcosine or placebo

  • Impact assessment of sarcosine versus placebo on oculomotoric parameters (saccadic and antisaccadic task in electrooculography). [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Both arms, before and after taking sarcosine or placebo

  • Impact assessment of sarcosine versus placebo on blood levels of glycine, sarcosine, BDNF and MMP-9. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Both arms, before and after taking sarcosine or placebo


Estimated Enrollment: 70
Study Start Date: January 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dietary Supplement: Sarcosine
Sarcosine Group
Dietary Supplement: Sarcosine

Sarcosine group patients will receive 2 grams of sarcosine once a day in the morning for 6 months.

Placebo group patients will receive 2 grams of placebo once a day in the morning for 6 months.

Other Names:
  • glycine transporter inhibitor
  • GlyT1 inhibitor
Placebo Comparator: Placebo
Control Group
Dietary Supplement: Sarcosine

Sarcosine group patients will receive 2 grams of sarcosine once a day in the morning for 6 months.

Placebo group patients will receive 2 grams of placebo once a day in the morning for 6 months.

Other Names:
  • glycine transporter inhibitor
  • GlyT1 inhibitor

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- Diagnosis of schizophrenia (ICD-10)

Other criteria related to the diagnosis verified during the selection visit:

  • The score for the PANSS negative symptoms subscale ≥ 21,
  • Severity of individual symptoms in the PANSS positive symptoms subscale may not exceed 3 points.

Exclusion Criteria:

General

  • lack of written informed consent,
  • risk of noncompliance during the study period,
  • patients who can not be assessed throughout the study period (eg. due to travel or vacations),
  • pregnancy or breastfeeding,
  • women of childbearing potential not using effective contraception (ie. birth control pill, surgical sterilization, hormonal contraceptive injection, IUD, contraceptive implant, patch, or condoms),
  • participation in another clinical study, currently or within 3 months before the visit of a selection panel
  • patients previously subjected to selection for this study.

Medical and Therapeutic Criteria Associated with schizophrenia

  • patients in acute psychosis, severe symptoms of productive,
  • patients taking clozapine,
  • declaring suicidal tendencies, history of committing suicide in the past year.

Associated with other psychiatric disorders

  • patients currently meeting criteria for ICD-10 diagnosis of mental disorder other than schizophrenia (in the last 6 months before the visit of a selection), confirmed by the MINI questionnaire
  • patients showing a prevalent and / or severe symptoms of depression (even without meeting criteria for major depressive episode according to ICD-10 criteria),
  • patients ever diagnosed with lifetime bipolar disorder,
  • patients with severe personality disorders, particularly type of antisocial, borderline, or histrionicznego that could affect the assessment of test results.

Other

  • abuse or addiction to alcohol or psychoactive substances (excluding nicotine) within the last 6 months, according to the criteria of ICD-10, confirmed by the MINI questionnaire,
  • disturbances occurring in the form of somatic according to ICD-10 criteria,
  • Delirium or dementia according to ICD-10 criteria,
  • current diagnosis of neurological diseases (eg, stroke, seizures, migraine, multiple sclerosis),
  • liver failure (ie, cirrhosis or active liver disease), diagnosed acute or chronic hepatitis,
  • severe or uncontrolled somatic disease that could affect the course of the study (eg cancer, cardiovascular, respiratory, metabolic or oral, severe renal failure, unstable diabetes type I or II, morbid obesity, untreated or uncontrolled hypertension, clinically significant blood),
  • thyroid dysfunction (especially hypothyroidism) untreated or uncontrolled, T - thyroid hormones treatment started, terminated or modified in the 3 months before the selection visit,
  • hormone replacement therapy started, terminated or modified in the 3 months before the selection visit.
  • recognized disorders of hemostasis,

Associated with a prior or concomitant treatment Particular caution should be maintained when using drugs likely to affect the central nervous system - their mechanism of action could affect the course of the study. Use of these substances after the selection visit is not allowed.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01503359

Contacts
Contact: Dominik Strzelecki, MD, PhD +48 42 6757236 dominik.strzelecki@umed.lodz.pl
Contact: Jolanta Rabe-Jabłońska, MD, PhD +48 42 6757371 jolanta.rabe-jablonska@umed.lodz.pl

Locations
Poland
Central Clinical Hospital Recruiting
Łódź, Czechosłowacka 8/10, Poland, 92-216
Contact: Dominik Strzelecki, MD, PhD    +48 42 6757236    dominik.strzelecki@umed.lodz.pl   
Sponsors and Collaborators
Medical Universtity of Lodz
Investigators
Principal Investigator: Dominik Strzelecki, MD, PhD Department of Affective and Psychotic Disorders, Medical University of Lodz
Study Chair: Jolanta Rabe-Jabłońska, MD, PhD Department of Affective and Psychotic Disorders, Medical University of Lodz
  More Information

Publications:

Responsible Party: Dominik Strzelecki MD PhD, Principal Investigator, Medical Universtity of Lodz
ClinicalTrials.gov Identifier: NCT01503359     History of Changes
Other Study ID Numbers: SAR-001, N N402 268836
Study First Received: December 30, 2011
Last Updated: February 1, 2012
Health Authority: Poland: Ministry of Science and Higher Education

Keywords provided by Medical Universtity of Lodz:
glutamic acid
sarcosine
NMDA
schizophrenia

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Glycine
Glycine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 23, 2014